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Semax

ACTH(4-10) analogue, Heptapeptide SEMAX

Quick Stats
Studies 172
Trials 37
Completed PHASE3 INTERVENTIONAL NCT02697734

Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The purpose of this study was to confirm efficacy and safety of osilodrostat for the treatment of patients with Cushing's disease who are candidates for medical therapy.

Detailed Description

The study LCI699C2302 (LINC-4) is a multi-center, randomized, double-blind study to evaluate the safety and efficacy of osilodrostat in patients with Cushing's disease. Enrolled patients were initially randomized to either osilodrostat or placebo, in a 2:1 ratio, for a 12-week double-blind period (Period 1). Randomization was stratified by history of pituitary radiation. After Week 12, all patients received open-label osilodrostat until the end of the Core phase at Week 48 (Period 2). After Week 48, patients could join an optional 48 week extension period.

Interventions

Name: osilodrostat
Type: DRUG
Description: In the form of filmcoated tablets for oral administration, in the following dose strengths: 1 mg, 5 mg, 10 mg, and 20 mg.
Name: osilodrostat Placebo
Type: DRUG
Description: Matching Placebo in the form of filmcoated tablets for oral administration

Primary Outcomes

Measure: Percentage of Randomized Participants With a Complete Response
TimeFrame: at Week 12
Description: A complete responder at week 12 is defined as a participant who had a mean urine free cortisol ≤ upper limit of normal (mUFC ≤ ULN) at Week 12. Participants who had a missing mUFC assessment at Week 12 were counted as non-responders for the primary endpoint.

Trial Information

NCT ID

NCT02697734

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Novartis Pharmaceuticals

Last Updated

December 15, 2025